Concentrated Exposure and Response Prevention for Children With Obsessive-compulsive Disorder

A Single Group Evaluation of Concentrated Exposure and Response Prevention for Children With Obsessive-compulsive Disorder

The goal of this clinical trial is to evaluate the preliminary outcomes of concentrated exposure and response prevention for children with obsessive-compulsive disorder (OCD) in regular clinical practice. It is a non-randomised open label evaluation where children 6-12 years with OCD who are patients at the Child and Adolescent Psychiatry (CAP) at Uppsala University Hospital will be rectruited together with their legal guardians. The treatment will be delivered by trained therapists in regular outpatient care.

The main question the study aims to answer is:

What are the preliminary treatment effects of concentrated exposure and response prevention with regards to OCD-symptoms, functional impact, family accomodation and clinician ratings of severity and improvement?

Participants will receive psychoeducation (in group format) and exposure and response prevention (9-12h concentrated to one week, individual format).

Outcomes will be measured on structured interviews, clinician ratings, and validated questionnaires pre-treatment, post-treatment and at a six month follow-up.

Study Overview

• Status: Recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Behavioral: Concentrated exposure and response prevention

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vendela Zetterqvist, Ph D, Associate Professor; Phone Number: +46 (0)768107060; Email: vendela.zetterqvist@uu.se

Study Locations

• Sweden
  • Region Uppsala
    • Uppsala, Region Uppsala, Sweden, 751 85
      • Recruiting
      • Uppsala University Hospital
      • Contact: Vendela Zetterqvist, Ph D, Associate Professor; Phone Number: +46 (0)768107060; Email: vendela.zetterqvist@uu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient fulfills the diagnostic criteria of obsessive-compulsive disorder
• The patient and the legal guardians have said yes to receiving the concentrated exposure with response prevention - treatment

Exclusion Criteria:

• The patient/legal guardians are unable to communicate in Swedish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Concentrated exposure and response prevention; The intervention consists of: Psychoducation for the patients (1 session, 2-3h in group format), psychoeducation for the legal guardians (1 session, 3h in group format), exposure and response prevention (3-4 sessions, 9-12h over the course of one week, individual format), group reunions for sharing experiences, motivational work and relapse prevention ( 2 sessions, 3h)

Behavioral: Concentrated exposure and response prevention; The intervention consists of: Psychoducation for the patients (1 session, 2-3h in group format), psychoeducation for the legal guardians (1 session, 3h in group format), exposure and response prevention (3-4 sessions, 9-12h over the course of one week, individual format), group reunions for sharing experiences, motivational work and relapse prevention ( 2 sessions, 3h); Other Names: cognitive behavioral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childrens Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)	The Childrens Yale-Brown Obsessive-Compulsive Scale is a semi-structured interview made up of 10 items rated on a 5-point Likert scale evaluating the severity of Obsessions and Compulsions across five dimensions; Frequency, Interference, Distress, Resistance, and Control, during the previous week and up to the time of interview. The total score varies between 0 and 40. Higher scores indicate higher severity of Obsessions and Compulsions.	pre-intervention; one week after the intervention; six months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression (CGI)	The Clinical Global Impression is a brief, stand-alone assessment of the clinicians view of the patients global functioning prior to and after initiating treatment. It comprises two one-item measures evaluating (a) severity of psychopathology from 1 to 7 where a higher score indicates a higher severity, and (b) change from the initiation of treatment from 1 to 7, where a lower score indicates more improvement (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse)	pre-intervention; one week after the intervention; six months after the intervention
Dimensional Obsessive-Compulsive Scale - Child Version (DOCS-CV)	The Dimensional Obsessive-Compulsive Scale - Child Version is a 20-item self-report instrument that assesses the severity of Obsessive-Compulsive Disorder (OCD) symptoms along four empirically supported theme-based dimensions: (a) contamination, (b) responsibility for harm and mistakes, (c) incompleteness/symmetry, and (d) unacceptable (taboo) thoughts.over the preceding one month. The scale is developed for children and adolescents aged 7 to 17 years. Within each subscale, the five item scores are summed to produce a subscale score (range = 0-20). The four subscale scores can be summed to produce an overall DOCS total score (range = 0-80). Higher score indicate higher severity of Obsessive-Compulsive Disorder.	pre-intervention; one week after the intervention; six months after the intervention
The Obsessive Compulsive Inventory-Child Version (OCI-CV)	A 21-item self-report measure that assesses obsessive compulsive symptoms in children and adolescents aged 7 to 17 years over the preceding one month. It is a Likert-type rating scale, scored 0 to 2 (where 0 = never, 1 = sometimes and 2 = always). The total score varies between 0 and 42 where higher scores indicate more symptoms.	pre-intervention; one week after the intervention; six months after the intervention
Dimensional Obsessive-Compulsive Scale - Parent Version (DOCS-PV)	The Dimensional Obsessive-Compulsive Scale - Parent Version is a 20-item self-report instrument that assesses the severity of Obsessive-Compulsive Disorder (OCD) symptoms along four empirically supported theme-based dimensions: (a) contamination, (b) responsibility for harm and mistakes, (c) incompleteness/symmetry, and (d) unacceptable (taboo) thoughts.over the preceding one month. The scale is developed for parents or legal guardians to children and adolescents aged 7 to 17 years. Within each subscale, the five item scores are summed to produce a subscale score (range = 0-20). The four subscale scores can be summed to produce an overall DOCS total score (range = 0-80). Higher score indicate higher severity of Obsessive-Compulsive Disorder.	pre-intervention; one week after the intervention; six months after the intervention
The Family Accommodation Scale for Obsessive Compulsive Disorder - Self-Rated Version (FAS-SR)	Parental assessment that aims to measure family members participation in or facilitation of rituals and/or avoidance in obsessive-compulsive disorder. The first section consists of a symptom checklist for Obsessive Compulsive Disorder. The second section contains 19 items that examine the frequency of accommodating behaviors carried out by the relative. Each item is rated on a 5-point scale (0 = none/never, 4 = every day). The total score varies between 0 and 76 points. Higher scores indicate more family accommodation.	pre-intervention; one week after the intervention; six months after the intervention

Collaborators and Investigators

• Sponsor: Uppsala University Hospital
• Collaborators: Uppsala University
• Investigators: Principal Investigator: Vendela Zetterqvist, Ph D, Associate Professor, Uppsala University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Estimated): December 14, 2029
• Study Completion (Estimated): December 14, 2029

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 27, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric; Cognitive Behavioral Therapy; Exposure; Obsessive-compulsive disorder; Response prevention
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 2023-07331-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to restrictions in Swedish legislation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No